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Describes analytical methods development, optimization and
validation, and provides examples of successful methods development
and validation in high-performance liquid chromatography (HPLC)
areas. The text presents an overview of Food and Drug
Administration (FDA)/International Conference on Harmonization
(ICH) regulatory guidelines, compliance with validation
requirements for regulatory agencies, and methods validation
criteria stipulated by the US Pharmacopia, FDA and ICH.
The first book to focus entirely on reactions for analyte detection
and characterization,Reaction Detection in Liquid Chromatography
depicts off- and on-line, pre- and postcolumnapproaches that have
been successfully used for many classes of compounds, bothorganic
and inorganic, in high performance liquid chromatography.The book
gives special attention to methods and instrumentation associated
with postcolumnreaction detection, discussing theory, background,
principles, and equations .. .and also highlights major areas of
reaction chemistry, such as immobilized ( or solution)enzymatic
reactions, homogenous solution chemistry, photochemical derivation,
pairedionreagents, solid phase and solid supported reagents, and
reactions for inorganic species.In addition, Reaction Detection in
liquid Chromatography details the efficiencies of thevarious
reactions surveyed ... forecasts how the utility of each reaction
is likely to be enhancedby new research ... and gives data that
will allow the reader to reproducereaction-detection approaches for
new analytes and samples.Reaction Detection in Liquid
Chromatography is essential reading for analytical,
bioanalytical,quality control, and research and development
chemists. It also comprises a finereference for analysts involved
in development and applications of liquid chromatographyfor
specific qualitative and quantitative analyte identification; and
in-house, professionalseminars.
The alarm sounded by Canada's recently confirmed case of bovine
spongiform encephalopathy (BSE) has reaffirmed the exigency of
establishing improved safeguards and more aggressive surveillance
protocols in North America and around the world. Research
converging on the probable causative agent-prion proteins-calls for
intensive assessment of the headway gained in tracing prions,
testing for transmissible neurodegenerative diseases, and
developing methods for cornering the epidemic. Administered by an
illustrious panel of 36 international contributors, this timely
book marshals techniques for prion protein assay and diagnosis of
transmissible spongiform encephalopathies (TSEs).
Describes analytical methods development, optimization and
validation, and provides examples of successful methods development
and validation in high-performance liquid chromatography (HPLC)
areas. The text presents an overview of Food and Drug
Administration (FDA)/International Conference on Harmonization
(ICH) regulatory guidelines, compliance with validation
requirements for regulatory agencies, and methods validation
criteria stipulated by the US Pharmacopia, FDA and ICH.
Written for practitioners in both the drug and biotechnology
industries, the Handbook of Analytical Validation carefully
compiles current regulatory requirements on the validation of new
or modified analytical methods. Shedding light on method validation
from a practical standpoint, the handbook: Contains practical,
up-to-date guidelines for analytical method validation Summarizes
the latest regulatory requirements for all aspects of method
validation, even those coming from the USP, but undergoing
modifications Covers development, optimization, validation, and
transfer of many different types of methods used in the regulatory
environment Simplifying the overall process of method development,
optimization and validation, the guidelines in the Handbook apply
to both small molecules in the conventional pharmaceutical
industry, as well as well as the biotech industry.
Written for practitioners in both the drug and biotechnology
industries, this handbook carefully compiles current regulatory
requirements on the validation of new or modified analytical
methods. Shedding light on method validation from a practical
standpoint, it contains practical, up-to-date guidelines for
analytical method validation. It also covers development,
optimization, validation, and transfer of many different types of
methods used in the regulatory environment. Simplifying the overall
process of method development, optimization and validation, the
guidelines in the Handbook apply to both small molecules in the
conventional pharmaceutical industry, as well as the biotech
industry.
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